Biodesix VeriStrat Data Demonstrate Independent Prediction of Immunotherapy Outcomes for NSCLC Patients

BusinessWire

BOULDER, Colo. & SAN DIEGO–()–Biodesix® today presented new data demonstrating that the VeriStrat® test is predictive of outcomes for patients with non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors (ICIs) in the first-line setting, even when adjusted for PD-L1 status. Study results were presented at a poster session of the Multidisciplinary Thoracic Cancers Symposium in San Diego, titled, “Real-World Performance of Blood-Based Proteomic Profiling in Immunotherapy Treatment in Advanced Stage NSCLC.”

The prospectively designed observational study (NCT03289780) is currently enrolling NSCLC patients at 33 U.S. sites and will follow patient outcomes for 18 months. A pre-planned interim analysis was conducted with the first 1000 patients enrolled with at least 12 months follow-up. Results for the subset of patients with advanced NSCLC treated with a front-line ICI, with or without chemotherapy (n = 85; all frontline therapies n = 419), suggest that incorporating the host immune response as part of the initial patient assessment provides clinically meaningful information when choosing a frontline therapy for NSCLC.

Immune checkpoint inhibitors have emerged as standard treatment for wild-type patients with NSCLC based on established superiority over chemotherapy in efficacy. However, it is known that not all patients testing positive for PD-L1 respond to ICIs.

“Additional studies are needed to establish the clinical utility of biomarker testing when choosing appropriate treatment regimens,” said Patricia Rich, M.D., medical oncologist and Medical Director of Thoracic Oncology at Cancer Treatment Centers of America. “Real-world data from this large registry observational study suggests that the overall survival for patients receiving a frontline ICI added to chemotherapy, or alone, may not be significantly different from platinum-based chemotherapy. This is potentially good news for patients that are not eligible for ICI therapy, cannot tolerate it, or simply cannot afford it.”

When patients were stratified by the VeriStrat blood-based host response proteomic test, the individuals identified as VeriStrat Poor (~25 percent) had significantly lower overall survival with any ICI based regimen, compared to individuals identified as VeriStrat Good (~75 percent), even when adjusted for PD-L1 status in a multi-variate analysis.

Data highlights:

  • The VeriStrat test is predictive of outcomes for all treatment regimens and lines of therapy, including immunotherapy, even when adjusted for PD-L1 status
  • Patients with a VS Good result had significantly higher median OS compared to VS Poor patients on both immuno-monotherapy and immunotherapy in combination with chemotherapy
  • Patients with a VS Poor result did not benefit from treatment with immunotherapy or the addition of immunotherapy to platinum-based therapy

“Immunotherapy has improved outcomes for many advanced stage patients with NSCLC but is not beneficial for everyone. There is a clinical need for a test to predict outcomes, including overall survival and response, that helps guide physicians and patients to the right treatment strategy in order to save critical time, reduce unnecessary side effects, and minimize treatment cost for ineffective therapies,” said Linda Traylor, Ph.D., Vice President of Clinical Development and Medical Affairs for Biodesix. “These data add to the already extensive and growing body of evidence supporting the VeriStrat test results as predictive of outcomes across treatment choices, now including ICIs. Biodesix is focused on supporting research that identifies effective therapies to treat the aggressive VeriStrat Poor disease state.”

The VeriStrat test is a multivariate, mass-spectrometry based test that measures circulating proteins in the blood serum or plasma of patients with NSCLC. Test results assign a good (VS Good) or poor (VS Poor) classification to patient samples. Multiple studies support that patients with a VS Good result have a better prognosis than patients with a VS Poor result, independent of current clinical prognostic indicators and treatment choice. VeriStrat testing has been validated in more than 70 studies with more than 6,600 patients and is covered by Medicare and most private health insurers.

About Biodesix

Biodesix is a lung cancer diagnostic company addressing the continuum of patient care from early diagnosis of lung nodules through late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics with the power of artificial intelligence. Biodesix is the first company to offer three best-in class tests for patients with non-small cell lung cancer, and multiple pipeline tests including one with the potential to identify patients who may benefit from immunotherapies. The Biodesix Lung Reflex strategy integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours. The BDX-XL2 nodule test evaluates the risk of malignancy, enabling physicians to triage patients to the most appropriate course of action. Biodesix also partners with the world’s leading biotechnology and pharmaceutical companies to develop companion diagnostics. For more information about Biodesix, please visit www.biodesix.com.

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